FDA Adverse Event
Injury
Summary report: N
DERMABOND 2
MDR report key: 3030549
·
Received April 2, 2013
Report
- Report Number
- 2210968-2013-03275
- Event Type
- Injury
- Date Received
- April 2, 2013
- Report Date
- March 14, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- MPN
- PMA / PMN Number
- P960052
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT EXPERIENCED A RASH AROUND THE INCISION. THE TOPICAL SKIN ADHESIVE WAS REMOVED. HOWEVER, THE RASH SPREAD TO THE PATIENT'S FACE. ADDITIONAL INFORMATION TO BE REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134169 | DERMABOND 2 | ADHESIVE, TOPICAL SKIN | MPN | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |